CreoDent Solidex Custom Abutment

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K160436 ↗

FDA Product Code

NHA

FDA applicant

Creodent Prosthetics, Ltd.

Device Class

Class II

Regulation

21 CFR Part 872.3630

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Creodent Solidex Custom Abutment

  Class II

  FDA 510(k) K113738 Active Cleared 17 Sep 2013

• CreoDent Solidex Customized Abutment

  Class II

  FDA 510(k) K202909 Active Cleared 2 Apr 2021

• CREOKORREKT Aligners

  Class II

  FDA 510(k) K211427 Active Cleared 13 Oct 2022

• CreoDent Solidex Customized Abutment and Screw

  Class II

  FDA 510(k) K170100 Active Cleared 18 Jul 2017

• CreoDent Solidex Customized Abutment

  Class II

  FDA 510(k) K150012 Active Cleared 4 Jun 2015

• CreoDent Solidex Customized Abutment and Screw

  Class II

  FDA 510(k) K202095 Active Cleared 16 Dec 2020

See all devices from Creodent Prosthetics Ltd →

• What is the CreoDent Solidex Custom Abutment used for?

  The CreoDent Solidex Custom Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous, providing stable support for prosthetic restorations in dental implant applications.

• How is the CreoDent Solidex Custom Abutment supplied?

  The device is supplied as a custom abutment and screw system, manufactured by CreoDent Prosthetics, Ltd., meaning it is made to order based on individual patient or clinical specifications rather than as a standard off-the-shelf component.

• Is the CreoDent Solidex Custom Abutment sterile or single-use?

  The provided data does not describe the device as sterile, single-use, reusable, or MRI-safe, so no claims about sterility or reusability can be made based on the information given; users should consult the manufacturer’s labeling for specific handling and use instructions.

• What regulatory pathway was used for the CreoDent Solidex Custom Abutment?

  The device received FDA 510(k) clearance (K160436) as substantially equivalent to a predicate device, with product code NHA and review by the Dental advisory committee, indicating it followed the traditional 510(k) pathway for market authorization in the United States.